Pediatric ObesityVALÉNCT04677582
VALÉ: A Multidisciplinary Childhood Obesity Treatment Program for Latino Communities
A study testing Vidas Activas, famiLias saludablEs (VALE) in people with Pediatric Obesity, run by George Mason University at 2 sites in United States.
Trial summary
This proposal aims to test the initial feasibility and efficacy of a 10-week multidisciplinary pediatric weight management program among low-income Latino children, aged 5 to 11 years, from the Woodbridge, VA area. The following specific aims will be tested: Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Vidas Activas, famiLias saludablEs (VALE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Oct 2017to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pre-pubertal (girls must not have started menses)
- Of Latino/Hispanic descent (parent self-identified)
- BMI for age >85th percentile (based on CDC growth reference)
- Child between 5-11 years old
- Healthy (no known chronic diseases or regular medication)
- Parent/adult caregivers willing to participate in all study visits
Who cannot join
- Not of Latino/Hispanic descent
- <5 years old or >11 years old
- BMI for age <85th percentile
- Not pre-pubertal (girls have experienced their first menses)
- Child has learning deficits or acute/chronic medical condition
- Parent/guardian has no transportation or unable to participate in sessions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Featherstone Elementary School
Woodbridge, Virginia, 22191
Kilby Elementary School
Woodbridge, Virginia, 22191
About this study
Official title: Vidas Activas, famiLias saludablEs (Active Lives, Healthy Families) (VALÉ)
This proposal aims to test the initial feasibility and efficacy of a 10-week multidisciplinary pediatric weight management program among low-income Latino children, aged 5 to 11 years, from the Woodbridge, VA area. The following specific aims will be tested:
Read the detailed description
Specific Aim 1: To test the acceptability of a multidisciplinary group intervention targeted towards low-income Latino families with a child who is obese.
Specific Aim 2: To test the effectiveness of the intervention by determining differences in behavioral changes (i.e. nutrition and physical activity habits), anthropometric (BMI-for-age, body fat) and clinical health outcomes (i.e. blood pressure, blood biomarkers) between children exposed to the intervention program vs. control children.
- Conditions
- Pediatric Obesity
- Being tested
- Vidas Activas, famiLias saludablEs (VALE)
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vidas Activas, famiLias saludablEs (VALE)Behavioural
Families and Children allocated to the intervention will receive weekly group-based meetings over a 10-week period consisting of education and activities on healthy lifestyles. Graduate students/Research Assistants trained in nutrition, exercise and clinical psychology will lead the meetings. All activities will be culturally relevant (i.e. cooking healthy Latino recipes) and Spanish speaking students will be recruited to deliver the intervention. Participants will be involved on deciding activities and projects and while some sessions will meet as a family group with parents/guardians, others will meet separately.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive weekly education sessions about nutrition, exercise, and behavioral health. Receives: Behavioral: Vidas Activas, famiLias saludablEs (VALE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline BMI at 3 months and 6 months
body weight (kg)/height(m^2)
Measured: Baseline, 3 and 6 months
Change from Baseline Body Fat Percentage at 3 months and 6 months
% via bioelectric impedance
Measured: Baseline, 3 and 6 months
Change from Baseline Blood Pressure at 3 months and 6 months
Systolic \& Diastolic Blood Pressure
Measured: Baseline, 3 and 6 months
Change from Baseline Waist Circumference at 3 months and 6 months
cm
Measured: Baseline, 3 and 6 months
Change from Baseline HbA1c at 3 months and 6 months
HbA1c (%)
Measured: Baseline, 3 and 6 months
Change from Baseline Glucose at 3 months and 6 months
Glucose (mg/dL)
Measured: Baseline, 3 and 6 months
Change from Baseline Blood Lipids at 3 months and 6 months
LDL, HDL, TRG, TC (mg/dL)
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start4 Oct 2017
- Primary completion20 Jun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Jones, PhD, CSCS*D, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677582
- Sponsor's protocol ID
- 117702
- Acronym
- VALÉ
- Status last verified
- Dec 2020
- First submitted
- 9 Aug 2018
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vidas Activas, famiLias saludablEs (Active Lives, Healthy Families) (VALÉ)
- ClinicalTrials.gov ID
- NCT04677582
- Acronym / sponsor ID
- VALÉ / 117702
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 20 Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal aims to test the initial feasibility and efficacy of a 10-week multidisciplinary pediatric weight management program among low-income Latino children, aged 5 to 11 years, from the Woodbridge, VA area. The following specific aims will be tested:
Detailed description
Specific Aim 1: To test the acceptability of a multidisciplinary group intervention targeted towards low-income Latino families with a child who is obese.
Specific Aim 2: To test the effectiveness of the intervention by determining differences in behavioral changes (i.e. nutrition and physical activity habits), anthropometric (BMI-for-age, body fat) and clinical health outcomes (i.e. blood pressure, blood biomarkers) between children exposed to the intervention program vs. control children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Vidas Activas, famiLias saludablEs (VALE)The intervention group will receive weekly education sessions about nutrition, exercise, and behavioral health. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Pre-pubertal (girls must not have started menses)
- Of Latino/Hispanic descent (parent self-identified)
- BMI for age >85th percentile (based on CDC growth reference)
- Child between 5-11 years old
- Healthy (no known chronic diseases or regular medication)
Key exclusion criteria (6 listed)
- Not of Latino/Hispanic descent
- <5 years old or >11 years old
- BMI for age <85th percentile
- Not pre-pubertal (girls have experienced their first menses)
- Child has learning deficits or acute/chronic medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vidas Activas, famiLias saludablEs (VALE)Families and Children allocated to the intervention will receive weekly group-based meetings over a 10-week period consisting of education and activities on healthy lifestyles. Graduate students/Research Assistants trained in nutrition, exercise and clinical psychology will lead the meetings. All activities will be culturally relevant (i.e. cooking healthy Latino recipes) and Spanish speaking students will be recruited to deliver the intervention. Participants will be involved on deciding activities and projects and while some sessions will meet as a family group with parents/guardians, others will meet separately. | Behavioural | Intervention Group |
Primary outcome
Change from Baseline BMI at 3 months and 6 months
Time frame: Baseline, 3 and 6 months
body weight (kg)/height(m^2)
Change from Baseline Body Fat Percentage at 3 months and 6 months
Time frame: Baseline, 3 and 6 months
% via bioelectric impedance
Change from Baseline Blood Pressure at 3 months and 6 months
Time frame: Baseline, 3 and 6 months
Systolic \& Diastolic Blood Pressure
Change from Baseline Waist Circumference at 3 months and 6 months
Time frame: Baseline, 3 and 6 months
cm
Change from Baseline HbA1c at 3 months and 6 months
Time frame: Baseline, 3 and 6 months
HbA1c (%)
Change from Baseline Glucose at 3 months and 6 months
Time frame: Baseline, 3 and 6 months
Glucose (mg/dL)
Change from Baseline Blood Lipids at 3 months and 6 months
Time frame: Baseline, 3 and 6 months
LDL, HDL, TRG, TC (mg/dL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Jones, PhD, CSCS*D principal investigator
George Mason University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vidas Activas, famiLias saludablEs (VALE) in people with Pediatric Obesity, run by George Mason University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline BMI at 3 months and 6 months (time frame: Baseline, 3 and 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.